COVID-19Phase 3COV-AIDNCT04330638

Treatment of COVID-19 Patients With Anti-interleukin Drugs

A Phase 3 study testing Anakinra, Siltuximab and Tocilizumab in people with COVID-19, run by University Hospital, Ghent at 15 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Anakinra, Siltuximab and Tocilizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 342 participants
Where: 15 sitesBelgium
Study dates: 3 Apr 2020to 21 May 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Recent ( ≥ 6 days of flu-like symptoms or malaise yet ≤16 days of flu-like symptoms or malaise prior to randomization) infection with COVID-19.
Confident COVID-19 diagnosis confirmed by antigen detection test and/or PCR and/or positive serology, or any emerging and validated diagnostic laboratory test for COVID-19 within this period.
In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19 diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent (<24h) chest-CT scan (confirmed by a radiologist and pulmonary physician as probable COVID-19), and a typical clinical and chemical diagnosis with signs of cytokine release syndrome, a patient can be enrolled as probable COVID-19 infected. In all cases, this needs confirmation by later seroconversion.
Presence of hypoxia defined as PaO2/FiO2 below 350 while breathing room air in upright position or PaO2/FiO2 below 280 on supplemental oxygen and immediately requiring high flow oxygen device or mechanical ventilation
signs of cytokine release syndrome defined as ANY of the following:
serum ferritin concentration >1000 mcg/L and rising since last 24h

Show all 18Show fewer

single ferritin above 2000 mcg/L in patients requiring immediate high flow oxygen device or mechanical ventilation
lymphopenia defined as <800 lymphocytes/microliter) and two of the following extra criteria
Ferritin > 700 mcg/L and rising since last 24h
increased LDH (above 300 IU/L) and rising last 24h
D-Dimers > 1000 ng/mL and rising since last 24h
CRP above 70mg/L and rising since last 24h and absence of bacterial infection
if three of the above are present at admission, no need to document 24h rise
Chest X-ray or CT scan showing bilateral infiltrates within last 2 days
Admitted to specialized COVID-19 ward or an ICU ward taking care of COVID-19 patients
Age ≥ 18yrs
Male or Female
Willing and able to provide informed consent or legal representative willing to provide informed consent

Who cannot join

Patients with known history of serious allergic reactions, including anaphylaxis, to any of the study medications, or any component of the product.
mechanical ventilation > 24 h at Randomization
Patient on ECMO at time of screening
clinical frailty scale above 3 (This frailty score is the patient status before first symptoms of COVID-19 episode.)
active bacterial or fungal infection
unlikely to survive beyond 48h

Show all 17Show fewer

neutrophil count below 1500 cells/microliter
platelets below 50.000/microliter
Patients enrolled in another investigational drug study
patients on high dose systemic steroids (> 20 mg methylprednisolone or equivalent) for COVID-19 unrelated disorder
patients on immunosuppressant or immunomodulatory drugs
patients on current anti-IL1 or anti-IL6 treatment
signs of active tuberculosis
serum transaminase levels >5 times upper limit of normal
bowel perforation or diverticulitis
pregnant or breastfeeding females (all female subjects deemed of childbearing potential by the investigator must have negative pregnancy test at screening)
Women of childbearing potential must have a negative serum pregnancy test pre-dose on day 1. Woùmen of childbearing potential must consistently and correctly use (during the entire treatment period and 3 months after last reatment) 1 highly effective method for contraception.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Belgium15 sites

AZ Sint-Jan Brugge
Bruges, 8000
University Hospital Saint-Pierre
Brussels, 1000
Erasmus University Hospital
Brussels, 1070
University Hospital Saint-Luc
Brussels, 1200
University Hospital Antwerp
Edegem, 2650
Ziekenhuis Oost-Limurg
Genk, 3600
AZ Sint-Lucas
Ghent, 9000
University Hospital Ghent
Ghent, 9000
Jessa ZH
Hasselt, 3500
University Hospital Brussels
Jette, 1090
CHU Tivoli
La Louvière, 7100
CHR de la Citadelle
Liège, 4000
University Hospital Liège
Liège, 4000
Cliniques Saint-Pierre Ottignies
Ottignies-Louvain-la-Neuve, 1340
AZ Delta
Roeselare, 8800

Other trials in Belgium

About this study

Official title: A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome

Read the detailed description

There are currently no treatments directed at halting the cytokine storm and acute lung injury to stop the progression from manageable hypoxia to frank respiratory failure and ARDS in patients with COVID-19 infection. Preventing progression from early acute hypoxia and cytokine release syndrome to frank hypoxic respiratory failure and ARDS could have a huge impact on the foreseeable overflow of the ICU units. In ventilated patients, preventing the onset of ARDS, or shortening ICU stay could also be crucial in this regard.

The clinical status after 15 days treatment is evaluated to measure the effectiveness of tocilizumab, tocilizumab and anakinra, siltuximab, siltuximab and anakinra and anakinra on restoring lung homeostasis,using single IV injection (siltuximab or tocilizumab) combined or not with daily subcutaneous injections of anakinra until 28 days or hospital discharge, whichever is first. During the treatment period, daily clinical assesments of severity, daily laboratory check-up, measurements of oxygen saturation (pulse oximetry) in relation to FiO2, regular arterial blood gas measurements, regular chest X-rays, chest CT scans on indication will be performed.

Conditions: COVID-19
Being tested: Usual Care, Anakinra, Siltuximab, Tocilizumab
Keywords: Acute Lung Injury, Hypoxia, Acute Respiratory Distress Syndrome, Corona virus, COVID-19, SARS (Severe Acute Respiratory Syndrome), Systemic Cytokine release Syndrome
Medical subject headings: COVID-19, Acute Lung Injury, Hypoxia, Respiratory Distress Syndrome, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Usual CareOther
Usual Care
AnakinraDrug
Also called KINERET®
Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
SiltuximabDrug
Also called SYLVANT®
Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
TocilizumabDrug
Also called ROACTEMRA®
Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection

Study groups in NCT04330638
Study group	Role	What they receive
Usual Care	Placebo comparator	Not described Receives: Other: Usual Care
Anakinra	Active comparator	Not described Receives: Drug: Anakinra
Siltuximab	Active comparator	Not described Receives: Drug: Siltuximab
Anakinra + Siltuximab	Active comparator	Not described Receives: Drug: Anakinra; Drug: Siltuximab
Tocilizumab	Active comparator	Not described Receives: Drug: Tocilizumab
Anakinra + Tocilizumab	Active comparator	Not described Receives: Drug: Anakinra; Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Clinical Improvement
Time to Clinical Improvement is defined as the time from randomization to either an increase of at least two points on a six category ordinal scale from the status at randomization or live discharge from the hospital.The 6-point ordinal scale for clinical improvement is defined as 1 = Death; 2 = Hospitalized, on invasive mechanical ventilation or ECMO; 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = Hospitalized, requiring supplemental oxygen; 5 = Hospitalized, not requiring supplemental oxygen; 6 = Not hospitalized. A higher score represent a better outcome
Measured: at day 15

Secondary outcomes (13)

Time Untill Discharge
Measured: during hospital admission (up to 28 days)
Time Until Independence From Supplemental Oxygen or Discharge
Measured: during hospital admission (up to 28 days)
Time Until Independence From Invasive Ventilation
Measured: during hospital admission (up to 54 days)
Number of Days in ICU
Measured: during hospital admission (up to 28 days)
Number of Days in ICU in Patients Ventilated at Day of Randomization
Measured: during hospital admission (up to 28 days)
Number of Days Without Supplemental Oxygen Use
Measured: during hospital admission (up to 28 days)
Number of Invasive Ventilator Days
Measured: during hospital admission (up to 28 days)
Number of Invasive Ventilator Days in Patients Ventilated at Day of Randomization
Measured: during hospital admission (up to 28 days)
Number of Invasive Ventilator-free Days
Measured: during hospital admission (up to 28 days)
Number of Invasive Ventilator-free Days in Patients Ventilated at Day of Randomization
Measured: during hospital admission (up to 28 days)
Percentage of Days in ICU
Number of days the participants were ventilated, relative to the number of days participants were alive during the first 28 days after randomization. This was calculated as the number of days with need for invasive ventilation / number of days alive during first 28 days, multiplied by 100 (to obtain a percentage).
Measured: first 28 days after randomization
Percentage of Invasive Ventilator Days
Number of days the participant spent in the ICU, relative to the number of days the patient was alive during the first 28 days after randomization. This was calculated as the number of days in ICU during first 28 days / number of days alive during first 28 days, multiplied by 100 (to obtain a percentage).
Measured: the first 28 days after randomization
Time Until First Use of High-flow Oxygen Device, Ventilation, or Death
Measured: during hospital admission (up to 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 202021 May 2021

First posted1 Apr 2020
Study start3 Apr 2020
Primary completion20 Dec 2020
Study completion21 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by University Hospital, GhentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 342 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04330638
Sponsor's protocol ID: COV-AID
Acronym: COV-AID
Status last verified: Feb 2023
First submitted: 31 Mar 2020
Last updated: 14 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Davidson M, Menon S, Chaimani A, Evrenoglou T, Ghosn L, Grana C, Henschke N, Cogo E, Villanueva G, Ferrand G, Riveros C, Bonnet H, Kapp P, Moran C, Devane D, Meerpohl JJ, Rada G, Hrobjartsson A, Grasselli G, Tovey D, Ravaud P, Boutron I. Interleukin-1 blocking agents for treating COVID-19. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD015308. doi: 10.1002/14651858.CD015308.
PubMed 35080773
Declercq J, Van Damme KFA, De Leeuw E, Maes B, Bosteels C, Tavernier SJ, De Buyser S, Colman R, Hites M, Verschelden G, Fivez T, Moerman F, Demedts IK, Dauby N, De Schryver N, Govaerts E, Vandecasteele SJ, Van Laethem J, Anguille S, van der Hilst J, Misset B, Slabbynck H, Wittebole X, Lienart F, Legrand C, Buyse M, Stevens D, Bauters F, Seys LJM, Aegerter H, Smole U, Bosteels V, Hoste L, Naesens L, Haerynck F, Vandekerckhove L, Depuydt P, van Braeckel E, Rottey S, Peene I, Van Der Straeten C, Hulstaert F, Lambrecht BN. Effect of anti-interleukin drugs in patients with COVID-19 and signs of cytokine release syndrome (COV-AID): a factorial, randomised, controlled trial. Lancet Respir Med. 2021 Dec;9(12):1427-1438. doi: 10.1016/S2213-2600(21)00377-5. Epub 2021 Oct 29.
PubMed 34756178
Brands X, de Vries FMC, Uhel F, Haak BW, Peters-Sengers H, Schuurman AR, van Engelen TSR, Lutter R, Cremer OL, Bonten MJ, Schultz MJ, Scicluna BP, van der Poll T; MARS Consortium. Plasma Ferritin as Marker of Macrophage Activation-Like Syndrome in Critically Ill Patients With Community-Acquired Pneumonia. Crit Care Med. 2021 Nov 1;49(11):1901-1911. doi: 10.1097/CCM.0000000000005072.
PubMed 33935163
Maes B, Bosteels C, De Leeuw E, Declercq J, Van Damme K, Delporte A, Demeyere B, Vermeersch S, Vuylsteke M, Willaert J, Bolle L, Vanbiervliet Y, Decuypere J, Libeer F, Vandecasteele S, Peene I, Lambrecht B. Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 3;21(1):468. doi: 10.1186/s13063-020-04453-5.
PubMed 32493441

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome
ClinicalTrials.gov ID: NCT04330638
Acronym / sponsor ID: COV-AID / COV-AID
Conditions: COVID-19
Keywords: Acute Lung Injury, Hypoxia, Acute Respiratory Distress Syndrome, Corona virus, COVID-19, SARS (Severe Acute Respiratory Syndrome), Systemic Cytokine release Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 342 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Collaborators: Belgium Health Care Knowledge Centre
Study start: 3 Apr 2020 (actual)
Primary completion: 20 Dec 2020 (actual)
Study completion: 21 May 2021 (actual)
First posted: 1 Apr 2020 (actual)
Results: Posted 14 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Usual Care	Placebo comparator	Other: Usual Care
Anakinra	Active comparator	Drug: Anakinra
Siltuximab	Active comparator	Drug: Siltuximab
Anakinra + Siltuximab	Active comparator	Drug: Anakinra, Drug: Siltuximab
Tocilizumab	Active comparator	Drug: Tocilizumab
Anakinra + Tocilizumab	Active comparator	Drug: Anakinra, Drug: Tocilizumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Recent ( ≥ 6 days of flu-like symptoms or malaise yet ≤16 days of flu-like symptoms or malaise prior to randomization) infection with COVID-19.
Confident COVID-19 diagnosis confirmed by antigen detection test and/or PCR and/or positive serology, or any emerging and validated diagnostic laboratory test for COVID-19 within this period.
In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19 diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent (<24h) chest-CT scan (confirmed by a radiologist and pulmonary physician as probable COVID-19), and a typical clinical and chemical diagnosis with signs of cytokine release syndrome, a patient can be enrolled as probable COVID-19 infected. In all cases, this needs confirmation by later seroconversion.
Presence of hypoxia defined as PaO2/FiO2 below 350 while breathing room air in upright position or PaO2/FiO2 below 280 on supplemental oxygen and immediately requiring high flow oxygen device or mechanical ventilation
signs of cytokine release syndrome defined as ANY of the following:

Key exclusion criteria (17 listed)

Patients with known history of serious allergic reactions, including anaphylaxis, to any of the study medications, or any component of the product.
mechanical ventilation > 24 h at Randomization
Patient on ECMO at time of screening
clinical frailty scale above 3 (This frailty score is the patient status before first symptoms of COVID-19 episode.)
active bacterial or fungal infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Usual CareUsual Care	Other	Usual Care
AnakinraAlso: KINERET®Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first	Drug	Anakinra, Anakinra + Siltuximab, Anakinra + Tocilizumab
SiltuximabAlso: SYLVANT®Siltuximab will be given via single IV infusion at a dose of 11 mg/kg	Drug	Anakinra + Siltuximab, Siltuximab
TocilizumabAlso: ROACTEMRA®Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection	Drug	Anakinra + Tocilizumab, Tocilizumab

Primary outcome

Time to Clinical Improvement
Time frame: at day 15
Time to Clinical Improvement is defined as the time from randomization to either an increase of at least two points on a six category ordinal scale from the status at randomization or live discharge from the hospital.The 6-point ordinal scale for clinical improvement is defined as 1 = Death; 2 = Hospitalized, on invasive mechanical ventilation or ECMO; 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = Hospitalized, requiring supplemental oxygen; 5 = Hospitalized, not requiring supplemental oxygen; 6 = Not hospitalized. A higher score represent a better outcome

13 secondary outcomes

Time Untill Discharge
Time frame: during hospital admission (up to 28 days)
Time Until Independence From Supplemental Oxygen or Discharge
Time frame: during hospital admission (up to 28 days)
Time Until Independence From Invasive Ventilation
Time frame: during hospital admission (up to 54 days)
Number of Days in ICU
Time frame: during hospital admission (up to 28 days)
Number of Days in ICU in Patients Ventilated at Day of Randomization
Time frame: during hospital admission (up to 28 days)
Number of Days Without Supplemental Oxygen Use
Time frame: during hospital admission (up to 28 days)
Number of Invasive Ventilator Days
Time frame: during hospital admission (up to 28 days)
Number of Invasive Ventilator Days in Patients Ventilated at Day of Randomization
Time frame: during hospital admission (up to 28 days)
Number of Invasive Ventilator-free Days
Time frame: during hospital admission (up to 28 days)
Number of Invasive Ventilator-free Days in Patients Ventilated at Day of Randomization
Time frame: during hospital admission (up to 28 days)
Percentage of Days in ICU
Time frame: first 28 days after randomization
Percentage of Invasive Ventilator Days
Time frame: the first 28 days after randomization
Time Until First Use of High-flow Oxygen Device, Ventilation, or Death
Time frame: during hospital admission (up to 28 days)

Results and safety

Results posted to the registry on 14 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	74	56
Anakinra: IL1-blocker	44	30
Siltuximab: IL-6 Blocker	75	52
Anakinra + Siltuximab	36	27
Tocilizumab: IL-6 Blocker	81	65
Anakinra + Tocilizumab	32	25

Primary outcome: Time to Clinical Improvement

Time frame: at day 15. Median (95% Confidence Interval). Unit: days

Measure	IL 1 Blockade n = 112	No IL-1 Blockade n = 230	IL-6 Blockade n = 227	No IL-6 Blockade n = 115
Value	12 (10 to 16)	12 (10 to 15)	11 (10 to 16)	12 (11 to 16)

Population analysed: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE's are recorded from randomisation until the end of the study, 5 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	14 of 74 (18.9%)	37 of 74 (50%)	9 of 74
Anakinra	12 of 44 (27.3%)	25 of 44 (56.8%)	10 of 44
Siltuximab	21 of 75 (28%)	15 of 75 (20%)	15 of 75
Anakinra + Siltuximab	8 of 36 (22.2%)	17 of 36 (47.2%)	6 of 36
Tocilizumab	15 of 81 (18.5%)	35 of 81 (43.2%)	10 of 81
Anakinra + Tocilizumab	9 of 32 (28.1%)	17 of 32 (53.1%)	5 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35080773Davidson M, Menon S, Chaimani A, Evrenoglou T, Ghosn L, Grana C, Henschke N, Cogo E, Villanueva G, Ferrand G, Riveros C, Bonnet H, Kapp P, Moran C, Devane D, Meerpohl JJ, Rada G, Hrobjartsson A, Grasselli G, Tovey D, Ravaud P, Boutron I. Interleukin-1 blocking agents for treating COVID-19. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD015308. doi: 10.1002/14651858.CD015308.
Derived from this study: PubMed 34756178Declercq J, Van Damme KFA, De Leeuw E, Maes B, Bosteels C, Tavernier SJ, De Buyser S, Colman R, Hites M, Verschelden G, Fivez T, Moerman F, Demedts IK, Dauby N, De Schryver N, Govaerts E, Vandecasteele SJ, Van Laethem J, Anguille S, van der Hilst J, Misset B, Slabbynck H, Wittebole X, Lienart F, Legrand C, Buyse M, Stevens D, Bauters F, Seys LJM, Aegerter H, Smole U, Bosteels V, Hoste L, Naesens L, Haerynck F, Vandekerckhove L, Depuydt P, van Braeckel E, Rottey S, Peene I, Van Der Straeten C, Hulstaert F, Lambrecht BN. Effect of anti-interleukin drugs in patients with COVID-19 and signs of cytokine release syndrome (COV-AID): a factorial, randomised, controlled trial. Lancet Respir Med. 2021 Dec;9(12):1427-1438. doi: 10.1016/S2213-2600(21)00377-5. Epub 2021 Oct 29.
Derived from this study: PubMed 33935163Brands X, de Vries FMC, Uhel F, Haak BW, Peters-Sengers H, Schuurman AR, van Engelen TSR, Lutter R, Cremer OL, Bonten MJ, Schultz MJ, Scicluna BP, van der Poll T; MARS Consortium. Plasma Ferritin as Marker of Macrophage Activation-Like Syndrome in Critically Ill Patients With Community-Acquired Pneumonia. Crit Care Med. 2021 Nov 1;49(11):1901-1911. doi: 10.1097/CCM.0000000000005072.
Derived from this study: PubMed 32493441Maes B, Bosteels C, De Leeuw E, Declercq J, Van Damme K, Delporte A, Demeyere B, Vermeersch S, Vuylsteke M, Willaert J, Bolle L, Vanbiervliet Y, Decuypere J, Libeer F, Vandecasteele S, Peene I, Lambrecht B. Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 3;21(1):468. doi: 10.1186/s13063-020-04453-5.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bart Lambrecht, MD, PhD principal investigator

University Hospital, Ghent

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anakinra, Siltuximab and Tocilizumab in people with COVID-19, run by University Hospital, Ghent at 15 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Clinical Improvement (time frame: at day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04330638, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.